Intralesional Ronkyla Plus Injection for the Treatment of Superficial Lipoma
Recruiting
Phase 1
Interventional Study
Lipoma
Submental Fullness
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 56 (estimated)
- Sponsor
- Glonova Pharma Co., Ltd · Industry
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About This Trial
This study aims to evaluate the safety, efficacy, and pharmacokinetics of Ronkyla Plus, a combinational drug that forms a hydrogel at the injection site, promising a better experience of lipolysis injection for the treatment of superficial lipoma. The study consists of a Part I dose-escalation study to investigate the drug's maximum tolerated dose (MTD) for this indication and a Part II study for …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Healthy male or female adults aged 18 to 65 years, inclusive.
2. One or more superficial lipomas, based on clinical diagnosis, which are accessible for treatment and assessment, are quantifiable along at least 2 perpendicular diameters, and have the following characteristics:…
Contacts